Securing a Medical Device to a Valve Instrument

ABSTRACT

Apparatus and techniques for securing a medical device with hemostasis valve are described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.14/514,815, filed Oct. 15, 2014, which claims the benefit of U.S.Provisional Application Ser. No. 61/891,312, filed Oct. 15, 2013. Thedisclosures of the prior applications are considered part of (and areincorporated by reference in) the disclosure of this application.

TECHNICAL FIELD

This disclosure relates to securing a medical device (e.g., a catheteror other elongate device) to a valve instrument (e.g., a hemostasisvalve or other medical valve device). In particular embodiments, thisdisclosure relates to apparatus and techniques for securing a medicaldevice and hemostasis valve together.

BACKGROUND

Hemostasis valves are used during some interventional procedures tominimize back bleeding and to prevent the introduction of air that mayresult in an embolism, while permitting the introduction of medicine andmedical devices to blood vessels in a patient's circulatory system. Forexample, a hemostasis valve can be used to introduce wires, sheaths,catheters which may be equipped with balloons and lumens, and otherelongate medical devices into a vein or artery. Example proceduresinclude, but are not limited to, angiography, angioplasty andembolization procedures. In other examples, a hemostasis valve is usedduring a fluoroscopy procedure to introduce fluoroscopicallyidentifiable materials, e.g., barium dye, to observe the patient'scirculatory system. In some circumstances, interior portions of thehemostasis valve can be pressurized with liquid to prevent blood orgases from escaping.

Some hemostasis valves are y-shaped with three ports that areindividually associated with an arm of the “y”. The ports are configuredas input ports for accepting a medical device or a liquid, or as an exitport through which the medical device or liquid passes into thepatient's circulatory system. Other commercially available hemostasisvalves include additional arms, e.g., a double-y configuration, that hasan additional port for introducing a medical device or liquids throughthe valve and into the patient. Hemostasis valves can include a varietyof valve systems to control movement of liquids, medical devices, and soon in the valve. The valve systems typically include a primary valve,such as a three-way stopcock type valve, for a standard hemostasisvalve, and a variety of seals or mechanism for controllingaddition/removal of medical devices and fluids. One of the ports, forexample, an inlet port that is often axially align with the outlet port,can include a “twist-lock” or “push-pull lock” to control introductionof or removal of a medical device from the patient. Some elongatemedical devices used with hemostasis valves can be fed or withdrawn bymanipulating one of these lock devices to lock or seal the valve andthen to insert or withdraw the device to target where the medicine ordevice is located. For example, an access sheath (having one or moreguide wires therein) may be fed through an inlet port into the valve foreventual insertion into a vein.

The sizes of the inlet ports for hemostasis valves vary based ondifferent manufacturers. Thus, although the hemostasis valve can be aparticular French size indicating how large the valve is, the internalcomponents (especially the seal devices proximate to the inlet port(s))can be sized and configured differently between various manufacturers.

SUMMARY

Some embodiments described herein provide a universal adapter toolconfigured to secure an elongate medical device to an inlet port of ahemostasis valve (or other medical valve device) in a manner thatprovides an effect seal even when the outer size of the elongate medicaldevice is not matched to the inlet port size of the valve device. Inparticular embodiments, the adapter tool can be adhered or otherwiseengaged to an exterior surface of the elongate medical device so thatthe adapter tool provides a transition (and a sealed arrangement)between an inner valve component of a hemostasis valve and the exteriorsurface of the elongate medical device. In such circumstances, theadapter tool permits the elongate medical instrument to be used with avariety of hemostasis valves (or other medical valve devices) beyond thelimited types of hemostasis valves that are specifically manufactured tomate with the particular size of the elongate medical instrument.

Some embodiments of an adapter tool described herein include a bodyportion that has a tapered body portion (e.g, a linear taper forfrustroconical shape, a concave curved taper for hyperbolic conicalshape, a convex curved taper for a bulbous shape, or the like) andincludes one or more protrusions that extend outwardly from the taperedbody portion's primary axis to engage an inlet port from any of a rangeof differently sized inlet ports included on hemostasis valves fromdifferent manufacturers. Each protrusion can be shaped as a ring,threading, a segment of a thread, another protruding structure, or acombination. The body portion of the adapter tool can surround a lumenof the adapter tool, which is configured to engage with an exteriorsurface of an elongate a medical device for passage of the elongatemedical device into the hemostasis valve.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a cross-sectional view of a system, including an adapter tool,for securing a medical device to a valve instrument, in accordance withsome embodiments.

FIG. 2 is perspective view of the adapter tool of FIG. 1, in accordancewith some embodiments.

FIG. 3A is a perspective view of an adapter tool for securing a medicaldevice to a valve instrument, in accordance with additional embodiments.

FIG. 3B is a perspective view of a portion of an adapter tool forsecuring a medical device to a valve instrument, in accordance withfurther embodiments.

FIG. 3C is a perspective view of a portion of an adapter tool forsecuring a medical device to a valve instrument, in accordance withadditional embodiments.

FIG. 4 is a flow diagram illustrating a method for securing a medicaldevice with a valve instrument, such as a hemostasis, in accordance withsome embodiments.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENT

Referring to FIGS. 1-2, some embodiments of a medical device securementsystem 50 include an adapter tool 100 configured to secure an elongatemedical device 220 to an inlet port 202 of a medical valve device 200 (ahemostasis valve device in this embodiment). The adapter tool 100 has anumber of structural feature that cooperate to engage with elongatemedical device 220 while also providing an effective seal with a valvecomponent 210 even when the outer size of the elongate medical device220 is not matched to the inlet port size of the valve device 200. Asdescribed in more detail below, the adapter tool 100 can be optionallyadhered or otherwise engaged to an exterior surface 222 of the elongatemedical device 220 so that the adapter tool 100 provides a transitionbetween the inner valve component 210 of the hemostasis valve device 200and the exterior surface 222 of the elongate medical device 220.Moreover, in this embodiment, a distal body portion 112 of the adaptertool 100 can have a tapered shaped, thereby providing a outer dimensionfor engaging with the inner valve component 210 that progressivelyincreases as the insertion depth of the adapter tool 100 increases. Insuch circumstances, the adapter tool 100 can serve as a useful,universal adapter that permits the elongate medical device 220 to beused with a variety of hemostasis valve devices even when the hemostasisvalve device 200 is not specifically manufactured to mate with theparticular size of the elongate medical device 220.

The hemostasis valve device 200 used with the adapter tool 100 can beimplemented from any of a variety of proprietary designs based on themanufacturer of the valve device 200. For example, manufacturers oftenproduce hemostasis valve devices with differently sized inlet ports foraccepting differently sized access sheaths (or other medical devices)for interventional procedures. In this example, the inlet port 202 mayinclude a deformable seal component 210 with an opening that isconfigured to sealingly engage with an exterior surface of the accesssheath passing through it. In some embodiments, the hemostasis valve mayinclude multiple seal components (element 210 or having a differentconfiguration) to ensure fluid does not escape while the sheath isinserted or removed.

As previously described, the inlet ports of various hemostasis valvescan differ in size and configuration between various manufacturers,which can lead to circumstances in which the access sheath 220 (or otherelongate medical device) to be used by a practitioner at a hospitals,clinic, or radiological imaging center is not sized to perfectly matewith the inlet port 202 of the selected hemostasis valve device 200. Insome embodiments, the adapter tool 100 can be beneficial used in thosecircumstances for securing the access sheath 220 to the inlet port 202of the selected hemostasis valve device 200.

Still referring to FIGS. 1-2, particular embodiments of the adapter tool100 can be adhered or otherwise mounted to the exterior of the elongatemedical device 220 prior to distribution to the hospitals, clinic, orradiological imaging center. In such circumstances, the manufacturer ofthe elongate medical device 220 may bond the adapter tool 100 near adistal end 223 of the device 220 so that the adapter tool 100 is spacedapart from the distal 223 by a tip distance 110. In such embodiments,the tip distance 110 can be selected to have a sufficient length so thata distal tip region of the medical device 220 is exposed, therebyproviding the practitioner with the options of using the medical device220 with a hemostasis valves specifically configured to mate with theouter diameter of the distal end 223 (in which case the adapter tool 100remains external to the hemostasis device) or using the medical device220 with the hemostasis valve 200 that is configured to mate with alarger diameter device (in which case the adapter tool 100 is insertedinto to the hemostasis device 200). Alternatively, the adapter tool 100could being provided as a separate piece (e.g., apart from the medicaldevice 220), and the practitioner can subsequently adhere or otherwiseengage the adapter 100 to the exterior surface 222 of the medical device220 after determining that inlet port 202 of the hemostasis valve 200may not match perfectly with the exterior surface 222 of the medicaldevice 220.

In the various embodiments in which the adapter tool 100 is used forsecuring the medical device 220 to the hemostasis valve device 200, themedical device 220 and adapter tool 100 are inserted into the inlet port202 until the seal component 210 included in the inlet port 202 contactsthe tapered body portion 112 (and preferably at least one protrusion 118that extends outwardly from the tapered body portion 112). The adaptertool 100 and the inlet port 202 (e.g., including the seal component 210or the inlet port 202) can engage to form a tight seal, and preferably aliquid tight seal, by manipulating the adapter tool 100 into securecontact inside the inlet port 202. For example, an adapter tool 100 canbe press-fit or twist-fit into engagement so the hemostasis valve device200 and the adapter 100 are secured in a relative position and thusremain stationary relative to one another during an intravascularprocedure. In the embodiment depicted in FIG. 1, the adapter tool 100and hemostasis valve device 200 are secured in the relative position sothat a longitudinal axis 105 of the adapter tool 105 is generallyaxially aligned with a longitudinal axis 205 of the hemostasis valvedevice 200, thereby facilitating alignment of the access sheath 220 (orother elongate medical device) with the longitudinal axis 205 of thehemostasis valve device 200.

Still referring to FIGS. 1-2, the adapter tool 100 in this embodiment isconfigured to serve as a universal adapter for securing the medicaldevice 220 to the hemostasis valve device 200. As such, the adapter tool100 can be configured to fit a range of hemostasis valve devices. Forexample, the adapter tool 100 can be configured to fit hemostasis valvedevices from a variety of manufacturers having a range of differentlysized inlet ports included on such valve devices. The inlet ports canrange in size and configuration based on manufacturer design. Inparticular, the inlet port may define an opening that is a predeterminedsize, e.g., a particular French size, but has a specific configurationthat is proprietary to the manufacturer. The opening of the inlet portcan be designed for a particular purpose, such as a type of procedure,or designed to accommodate a type of medical device. The adapter tool100, however, can be mounted to the elongate medical device 220 so thatit can be conveniently used with the hemostasis valve device intendedfor a different type or different size of medical device.

As shown in FIG. 1, the depicted example of the hemostasis valve device200 may include an inlet port 202 with one or more seal components(e.g., inner seal component 210 and cap component 215 in thisembodiment). The cap component 215 includes an opening 216 that allowsthe elongate medical device 220 to move into or out of the hemostasisvalve 202. In this example, the opening 216 of the cap component 215 cancomprises polyisoprene or silicone rubber material, which therebyprovides a sealing engagement with the device (e.g., the adapter tool100 in this embodiment) engaged with the wall of the opening 216.Additionally or alternatively, the inner seal component 210 can providea flexible seal interface with the device (e.g., the adapter tool 100 inthis embodiment) engaged with the component 210. Also, the inlet regionof the hemostasis valve device 200 can be configured with differentlocking mechanisms, such as twist-locks or push-pull locks for lockingthe position of the adapter tool 100/medical device 220. It should beunderstood from the description herein that other embodiments of thehemostasis valve device 200 can employ other types of valve componentsto prevent blood drawback while permitting insertion/retraction ofadapter tool 100 during a procedure.

As shown in FIG. 2, the adapter tool 100 can be used with a variety ofmedical devices, sheath-type medical devices, e.g., extenders, or otherelongate medical devices that are used with a hemostasis valve. Examplemedical devices include catheters (including mini-catheters), probes,guide wires, lumen instruments, and other intravascular devices. Medicaldevices of this type can be inserted into a patient through thehemostasis valve device 200 or other device configured to offerhemostasis valve functionality. For example, an access sheath 220 (whichcan be used to advance one or more guide wires therethrough) is insertedinto the hemostasis valve 202 during an intravascular procedure asillustrated in FIG. 1. In this way, a physician can insert or retractthe guide wires into a vein or artery while maintaining a fluid seal.

Referring to FIG. 2, the adapter tool 100 can includes a body portion112 with a generally tapered shape. For example, the tapered shape maybe at least partially defined by a linear slope to provide afrustroconical shape. In another example, the tapered shape may be atleast partially defined by a curved slope, such as a concave slope toprovide a hyperbolic conical shape or a convex slope to provide abulbous shape. The extent to which the body portion 112 tapers relativeto the longitudinal axis 105 can be selected according to a number offactors. For example, the body portion 112 may have proportions (e.g.,slope or length in comparison to its radius) based on the range ofopenings into which it may be inserted, internal fluid pressure, openingsize, size of an expected medical device, expected sheath size, and soforth. For example, a body portion with a long length in comparison tothe radius of its base may not secure as well in comparison to a bodyportion with a larger diameter end radius in comparison to its length.

The body portion 112 can be axially aligned with the longitudinal axis105 of the adapter tool 105, which may extends through its center alongits maximum length. In some embodiments, the axis 105 is generallyperpendicular to the base radius of the body portion 112. Also, the bodyportion 112 may at least partially define a passage 116 that extendsalong the axis 105. For example, the passage 116 can be configured toaccept different sized sheaths of other elongate medical instruments. Insome embodiments, the interior wall 117 of the passage 116 can comprisea material (such as a flexible silicone) that is configured to deformslightly to accept a sheath device 220 while permitting the wall 117 ofthe passage 116 to form a tight seal around the sheath device 220, e.g.,a fluid tight seal.

In some implementations described herein, the adapter tool 100 isadhesively connected to the sheath device 220 or other elongate medicaldevice using, for example, a medical grade adhesive. The adhesive canform a seal (or supplement the seal) between the exterior surface 222 ofthe sheath device 220 and the wall 117 of the central passage 116. Amanufacturer, wholesaler, retailer, or other intermediary may fixedlysecure the adapter tool 116 to the medical device 220 so the medicaldevice 220 can be provided as a unit, e.g., a prepackaged sterile unit(having the adapter tool 100 mounted thereon) that is ready for end use.Alternatively, the adapter tool 100 can be configured to slidably engagethe sheath device 220 (free of any adhesive) during use. As previouslydescribed, the interior wall 117 of the passage 116 can comprise amaterial (such as a flexible silicone) that is configured to deformslightly in response to an insertion force of the sheath device 220slidably advancing through the passage and that is configured to restagainst and provide a frictional gripping force (and a sealingengagement) when the sheath device 220 comes to a stop within thepassage 116.

Referring again to FIGS. 1-2, some embodiments of the adapter tool 100include one or more protrusions 118 for engaging with a component of theinlet port 202 of the hemostasis valve device 200. The protrusions canbe configured to engage with, for instance, a seal (e.g., inner sealcomponent 210, the cap component 216, or the like) or a complaint wallthat at least partially forms the inlet port in order to form a tightseal around the protrusion 118. It is to be appreciated that in additionto the protrusions 118, the sealing component(s) of the inlet port 202can engage with, or at least partially engage with, a portion of theouter surface 120 of the body portion 112.

In some embodiments, the protrusions 118 extend outwardly from axis 105and the outer surface 120 of the body portion. For example, theprotrusions 118 may extend radially outward from the axis 105 of thetool 100. The body portion 112, the protrusions, or both can besymmetric about the axis 105 or about a longitudinal plane extendingalong the axis 105. As illustrated in the example in FIG. 2, each of theprotrusions 118 is shaped as a ring that protrudes beyond a majorportion of the outer surface 120 of the body portion 112. Theprotrusions 118 can have a variety of cross-sections (e.g., V-shaped,U-shaped), widths, and heights, depending on design preference, therange of hemostasis valves that it is to be used with, and otherfactors. Further, an adapter can include protrusions that have the sameor different cross-sectional: shapes, widths, height, shapes, hardness,and the like. For example, a protrusion 118 forming a ring near a narrowdistal end 122 of the tapered body portion 112 may have a smallercross-section, a different height, and/or a different shape than that ofa protrusion 118 that is adjacent a larger proximal end 124 of thetapered body portion 112.

In the embodiment depicted in FIG. 2, the protrusions 118 are axiallyaligned as annular rings of different diameters and axially spaced alongthe length of the body portion 112. In this configuration, theindividual protrusions 118 can protrude to different extents from theaxis 105 (e.g., have progressively increasing overall outer diameters),although individual protrusions may extend the same radial distance fromthe outer surface 120 of the body portion 112 (e.g., each ringprotrusion 118 in this embodiment extends ⅛-inch from the outer surface120). Accordingly, in such embodiments, a user can press-fit the adaptertool 100 into the inlet port 202 by pressing the adapter tool 100(optionally, along with the medical device 220 mounted therein) inwardlytowards the port 202 in a generally linear manner until one or moreprotrusions engage the corresponding seal component 210 of the port 202.For example, a user may press in the adapter tool 100 until the sealcomponent 210 comes in contact with a protrusion 118 of a particulardiameter, at which point, the adapter tool 100 is engaged so the sealcomponent 210 deforms sufficiently to provide a sealing engagementaround body portion 112.

In the embodiments in which the protrusions 118 are formed as rings, theindividual rings 118 can be spaced at uniform distances along the lengthof the axis 105. Alternatively, the rings 118 may be non-uniformlyspaced along the axis 105 (e.g., two or more rings may be clusteredabout an axial position) to afford slightly different diameters toaccount for manufacturing inconsistencies in the hemostasis valves,provide multiple contact points for engaging with the port, and soforth.

In addition to forming a liquid or pneumatically tight seal, the adaptertool 100 can be configured so it engages in a sufficiently tight mannerto prevent the adapter tool 100 from inadvertently withdrawing from thehemostasis valve 200 during manipulation of the medical device 220. Forexample, the adapter tool 100 is configured to achieve a sufficientlysnug fit so normal push-pull insertion or removal of the medical device220 can be achieved without loosening the adapter tool 100 from thehemostasis valve device 200.

As shown in FIG. 2, the adapter tool 100 may optionally include agrasping portion 126 that is structured to facilitate finger or handgrasping such as for insertion or removal of the adapter tool 100 to orfrom the hemostasis valve device 200. In the illustrated embodiment, thegrasping portion 126 is bounded by a pommel 128 that prevents orminimizes the likelihood of a user's fingers slipping when inserting theadapter in a press-fit manner. The contour of the grasping portion 126may be selected to facilitate an insertion, engaging, or removal action.Also, in some embodiments, the grasping portion 126 has an axial length(along the axis 105) that is greater than an axial length of the bodyportion 112 (which carries the protrusions 118). The grasping portion126 can be configured to press-fit the adapter tool 100 in a linearmanner so it seats it in the port 202 or to facilitate a rotating ortwisting action for threaded protrusions (described below). The graspingportion 126 can include texturing or include a surface treatment tofacilitate manipulation, e.g., gloved manipulation. It is to be apparentthat the grasping portion 126 may be formed of, or coated with amaterial to aid grasping. For example, a tacky outer layer (incomparison to other portions of the adapter) can be applied or co-formedin the grasping area.

The adapter tool 100 can be formed of a variety of biocompatible andsterilizable materials selected for performance characteristics.Characteristics include, but are not limited to, rigidity,deformability, resistance to degradation (thermal, radiation, water,light, electrical), inertness (e.g., chemically inert), resistance tocontamination or microbial growth, out-gassing, and so forth. Inembodiments, the adapter tool 100 is formed of a medical grade siliconeor polyisobutylene, polyisoprene, or other medical grade plastic/rubbermaterial, and copolymers thereof, and combinations thereof. In someinstances, the material forming the body portion is loaded orimpregnated with another material to give it a one or more physical,biological-related, or chemical properties. For example, the plastic forthe body portion is infused with a radiation blocking to make resistantto x-ray that may be used in a medical procedure.

Also, each of the protrusions 118 can be formed of the same material asthat of the body portion 112. Alternatively, each of the protrusions 118can be formed of a different material as that of the body portion 112,in which case the protrusion may be co-molded with the body portion 112.Each of the protrusions 118 can be formed of a mix of materials toprovide a variety of characteristics, such as: deformability, heatresistance, and so on. In some instances, a coating can be providedwhile the protrusions and/or body portion are formed of one or moreother materials. For example, a polytetrafluroethylene, e.g., Teflon,outer surface may be formed as part of a blow-molding process.

Referring now to FIG. 3A, some embodiments of an adapter tool 300 caninclude a protrusion configuration that is different from the adaptertool 100 illustrated in FIGS. 1-2. The adapter tool 300 in FIG. 3A canbe similarly configured to secure an elongate medical device to an inletport of a medical valve device (such as the hemostasis valve device200). The adapter tool 300 can engage with elongate medical device 220(FIG. 1) while also providing an effective seal with a valve component210 (FIG. 1) even when the outer size of the elongate medical device 220(FIG. 1) is not matched to the inlet port size of the valve device 200(FIG. 1). As previously described, the adapter tool 300 can provide atransition between the inner valve component 210 (FIG. 1) of thehemostasis valve device 200 (FIG. 1) and the exterior surface 222(FIG. 1) of the elongate medical device 220 (FIG. 1).

As shown in FIG. 3A, the adapter 300 includes at least one protrusion inthe form of a thread along the tapered body portion 312. In thisembodiment, a first protrusion 330 defines a first type of thread, and asecond protrusion 332 defines a second type of thread. The threadedprotrusions 330 and 332 are formed on different tapered regions 334 and336, respectively, of the body portion 312. In other words, the firstthreaded protrusion 332 extends outwardly from the first tapered region334 and the second threaded protrusion 336 extends outwardly from thesecond tapered region 336 to accommodate a larger sized port than thatof the first tapered region 334. As previously described, the taperedshape of each portion 334 and 336 may be at least partially defined by alinear slope or a curved slope.

The protrusions 330, 332 provide a thread about the axis 305 of theadapter tool 300 to permit engagement by rotating or twisting theadapter tool 300 into a port. The pitch, the profile, and/or directionof the threaded protrusions 330, 332 can be selected based on a varietyof factors including, selected seating compression, torque used toengage the threading with a port to ensure a tight seal, theprotrusion's rigidity/deformation characteristics, resistance to forcesapplied during a medical procedure (e.g., push-pull action), and so on.The threaded protrusions 330, 332 may have similar or differentcharacteristics. For example, the first threaded protrusion 330 may havea tighter pitch, have a narrower cross-section, and/or extend radiallyoutward to a different extent in comparison to the second threadedprotrusion.

The first protrusion 330 can have a pitch that twists in a firstdirection, e.g., clockwise. The second protrusion 332 can have a pitchthat is opposite that of the first, e.g., twists in a counter-clockwisedirection. The threaded protrusions 330, 332 can be configured toaccommodate different sized and/or types of inlet ports. For example,the first threaded protrusion 330 is configured to work with a firstsize range of inlet ports while the second threaded protrusion 332 isconfigured to work with a second size range.

The first and second threaded protrusions 330, 332 can be configured sothe adapter 300 may be inserted into a comparatively larger port withouthaving to engage the smaller threaded protrusion, e.g., the firstthreaded protrusion 330, with the port. In this configuration, theadapter 300 is inserted into the port until the port engages with thesecond threaded protrusion 332 (the larger protrusion) where it can besecured by twisting the adapter 300. This allows the adapter 300 to besecured without having to engage the first threaded protrusion 330 (thesmaller protrusion). In this configuration, the user does not have tohave to reverse direction from, for example, clockwise to counterclockwise to engage the second threaded protrusion. Moreover,cross-threading can be avoided. These features may be accomplished bysizing the protrusions 330, 332 so the adapter 300 can be insertedlinearly, thus bypassing the first threaded protrusion 330, before thesecond threaded protrusion 332 engages with the port. Configuring theadapter tool 300 in this manner, can minimize the rotation used to sealthe adapter in a larger port, and/or permit the adapter to accommodate alarger size range of ports.

Referring now to FIG. 3B, some embodiments of an adapter tool 300B canbe equipped with threaded protrusions that are segmented. Asillustrated, the threaded protrusions 340 are segmented so theprotrusions 340 extend only partially around the circumference of thebody portion 312, e.g., the protrusion is non-continuous about the outersurface 338. The protrusions 340 may be segmented to limit the rotationaction that is used to engage with the port. For example, segmentedprotrusions 340 (one is referenced) can permit the adapter tool 300B tobe linearly inserted into a port until a protrusion 340 contacts theport's seal component and then rotated to a limited extent, e.g., aquarter-turn is used to tighten the adapter tool 300B in the port.Constructing the adapter 300B in this way can increase convenience, useless material, and so forth. As illustrated, a second threadedprotrusion 332, similar to that of FIG. 3A, can be optionally includedalong the tapered body portion 312.

Referring now to FIG. 3C, some embodiments of an adapter tool 300C canbe equipped with a combination of different protrusions. In thisembodiment, a series of ring shaped protrusions 318 are included on afirst tapered region 342 of the tapered body portion 312 and a threadedprotrusion 332 is included of a second tapered region 346 so as toaccommodate a larger sized port and/or for a port that more readilyaccepts a threaded protrusion. As can be seen, the ring protrusions 318are substantially similar to those illustrated and described inconjunction with FIG. 2. As such, the adapter tool 300C can implementtwo different engagement modes based on port size, e.g., press-fit fornarrower ports and twist-fit for larger ports.

Optionally, the individual ring protrusions 318 can be associated with acorresponding groove 344. For instance, a ring protrusion 318 has acorresponding groove 344 that is adjacent the ring 318 but farther alongthe axis 305 away from a distal end 322. In this configuration, a sealcomponent (e.g., inner seal component 210) included on the inlet port202 (FIG. 1) can snap over the ring protrusion 318 and at leastpartially seal within the surface of the groove 344 to form a tightseal. Movement of the adapter/valve seal along the adapter's axis towardthe narrow end can be prevented by the engaged ring 318.

The following discussion describes methods that may be implemented inconjunction with the embodiments of the adapter tool described above.The techniques described below are independent of the structuresdescribed above, meaning that the techniques may be implemented in avariety of ways and are not necessarily limited to the structuresillustrated in FIGS. 1-3C.

Referring to FIG. 4, some embodiments of a method 400 can use an adaptertool for securing a medical device to a hemostasis valve device. In someexamples, the adapter tool 100, 300, 300B, or 300C can be used toprovide a transition between the inner valve component of the hemostasisvalve device and the exterior surface of the medical device. The methodcan be used to secure any of a variety of medical devices, such as thoseused in intravascular procedures.

Some embodiments of the method 400 may include operation 410, whichcomprises engaging a medical device within a passageway defined by anadapter tool. For example, a sheath 220 or other elongate medical devicecan be slidably or adhesive engaged within a passage 116 of the adaptertool 100 (FIGS. 1-2). As previously described, the medical device 220can be engaged with the adapter tool prior to packaging the combinationin a kit (e.g., preinstalled embodiments), or the medical device 220 canbe engaged with the adapter tool 100 during the interventional procedure(e.g., at the hospital or clinic) after a practitioner determines thatthe medical device 200 may not fit perfectly with the inlet port 202 ofthe hemostasis valve.

Still referring to FIG. 4, the method 400 may also include the operation420, which comprises installing a hemostasis valve in fluidcommunication with a blood vessel. For example, an outlet port of thehemostasis valve device 200 (FIG. 1) may be positioned in fluidcommunication with a vein or artery of a patient. Additionally, themethod 400 may include operation 430 in which the adapter tool isinserted into an inlet port of the hemostasis valve. As previouslydescribed, the adapter tool 100 (FIG. 1) can be adhered or slidablyengaged to an exterior surface 222 of the elongate medical device 220 toprovide a sealed engagement therebetween. In those embodiment, theoperation 430 would cause both the adapter tool 100 and the medicaldevice 220 (FIG. 1) to be simultaneously inserted into the inlet port202 (FIG. 1).

The method 400 may also include operation 440, in which at least oneprotrusion of the adapter tool is engaged with a seal component of theinlet port of the hemostasis valve device. For example, the adapter toolmay be equipped with one or more protrusions on a tapered body portion(some example illustrated in FIGS. 2, 3A, 3B, and 3C), and at least oneof the protrusions can be sized to engage with a seal component of thehemostasis valve device 200 (FIG. 1). As such, the adapter tool 100 canprovide a transition between the valve component of the hemostasis valvedevice 200 and the exterior surface 222 of the elongate medical device220 (FIG. 1). In some embodiments, a threaded protrusion that extendsradially outward from an adapter tool can be rotated into engagementwith a seal component of the inlet port to create a liquid tight seal.The liquid tight seal can be formed by applying sufficient torque on theadapter tool so the protrusion and/or at least a portion of the taperedbody portion engages with the seal component so the adapter tool isseated in the inlet port. The seal between the inlet port and theadapter tool can be caused by the thread and/or the portion of the outersurface deforming as the adapter tool is rotated into engagement.Rotation may occur in a clockwise or counter-clockwise direction. Theadapter's direction of rotation may depend on, for example, the sizeand/or configuration of the inlet port. In other embodiments, aring-shaped protrusion along the adapter tool can be press-fit intoengagement with the valve component, as previously described. Thus, auser can press the adapter tool into engagement so one or more of therings engage with the hemostasis valve device.

-   -   The method 400 may optionally include operation 450 in which a        fluid (e.g., medical fluid) or guide wire (or other elongate        instrument) is advanced through the medical device engaged with        the adapter tool. For example, as previously described, the        medical device 220 (FIG. 1) can serve as an access sheath that        permits a medical fluid, and imaging fluid, guide wires, or        other instruments to advance through the medical device 220 and        into the blood vessel coupled to the hemostasis valve device        200.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the scope of the invention. Accordingly,other embodiments are within the scope of the following claims.

What is claimed is:
 1. An adapter device for a medical devicecomprising: a generally tapered body portion configured to engage aninlet port of a hemostasis valve; the body portion defining a lumen toreceive a medical device for passage of the medical device into thehemostasis valve; the body portion including one or more protrusionsextending outwardly from a longitudinal axis of the body portion tosealingly engage with a component of the inlet port of the hemostasisvalve.
 2. The adapter device of claim 1, wherein the one or moreprotrusions comprise a series of annular ring protrusions havingdifferent outer diameters.
 3. The adapter device of claim 1, wherein theone or more protrusions comprise at least one threaded protrusion thatextends at least partially around an exterior of the generally taperedbody portion so the threaded protrusion extends outwardly from theprimary axis to different outer diameters along the threaded pitch ofthe protrusion.
 4. The adapter device of claim 3, wherein the threadedprotrusion extends continuously along a portion of the body portion. 5.The adapter device of claim 3, wherein the one or more protrusionscomprise a first threaded protrusion and a second threaded protrusionthat, respectively, extend at least partially around the an exterior ofthe generally tapered body portion, the first threaded protrusion beingthreaded in a clockwise direction and the second threaded protrusionbeing threaded in a counter-clockwise direction, the first and secondthreaded protrusions being located at different axial locations on theexterior of the generally tapered body portion along the primary axis.6. The adapter device of claim 5, wherein at least one of the first orsecond protrusions is discontinuous along its length.
 7. The adapterdevice of claim 5, wherein the first and second threaded protrusionshave different pitches.
 8. The adapter device of claim 5, wherein theadapter device is configured to permit engagement of the second threadedprotrusion with the inlet port of the hemostasis valve without having torotate the body portion in a direction opposite that used to thread thesecond threaded portion into engagement with the inlet port of thehemostasis valve.
 9. The adapter device of claim 8, wherein the lumendefined by the body portion comprises a flexible material configured tocomply in response to insertion of the medical device through the lumenand configured to provide a sealing engagement with an exterior surfaceof the medical device.
 10. The adapter device of claim 1, furthercomprising a grasping portion configured to be grasped during insertionof the generally tapered body portion into the inlet port of thehemostasis valve.
 11. An system for securing a medical device to amedical valve instrument, comprising: a medical device having anelongate body and an exterior surface; an adapter tool defining a lumenalong a longitudinal axis, the elongate body of the medical device beingpositioned with the lumen of the adapter tool so as to provide a sealedengagement between the adapter tool and the exterior surface of themedical device, wherein the adapter tool comprises: a generally taperedbody portion configured to engage an inlet port of a hemostasis valve,the generally tapered body portion surrounding the lumen and the medicaldevice therein, the generally tapered body portion including one or moreprotrusions extending outwardly from the longitudinal axis of the bodyportion to sealingly engage with a component of the inlet port of thehemostasis valve.
 12. The system of claim 11, wherein the one or moreprotrusions comprise a series of annular ring protrusions havingdifferent outer diameters.
 13. The system of claim 11, wherein the oneor more protrusions comprise at least one threaded protrusion thatextends at least partially around an exterior of the generally taperedbody portion so the threaded protrusion extends outwardly from theprimary axis to different outer diameters along the threaded pitch ofthe protrusion.
 14. The adapter device of claim 11, wherein the lumendefined by the body portion comprises a flexible material configured tocomply in response to insertion of the medical device through the lumenand configured to provide a sealing engagement with the exterior surfaceof the medical device.
 15. The adapter device of claim 1, wherein theadapter tool a grasping portion configured to be grasped duringinsertion of the generally tapered body portion into the inlet port ofthe hemostasis valve.
 16. A universal hemostasis valve adapter for anextender, comprising: a generally tapered body portion defining acentral passage configured to accept the extender for insertion into ahemostasis valve, the body portion including at least one radiallyextending protrusion disposed on a surface of the generally tapered bodyportion, the at least one radially extending protrusion configured toengage an entry port included on the hemostasis valve.
 17. The universalhemostasis valve adapter of claim 16, wherein the body portion hassufficient rigidity to retain its tapered shape, wherein the bodyportion is deformable to develop an at least partially liquid imperviousseal with the entry port.
 18. The universal hemostasis valve adapter ofclaim 16, wherein the at least one protrusion comprises a threadedprotrusion that extends at least partially around the tapered surface sothe threaded protrusion extends outwardly different extents along thethreaded protrusion.
 19. The universal hemostasis valve adapter of claim16, wherein the at least one protrusion comprises a first threadedprotrusion and a second threaded that, respectively, extend at leastpartially around the tapered surface, the first threaded protrusionbeing threaded in a clockwise direction and the second threadedprotrusion being threaded in a counter-clockwise direction.
 20. Theuniversal hemostasis valve adapter of claim 16, wherein the adapter isconfigured to permit engagement of the second threaded protrusion withthe entry port without having to rotate the body portion in a directionopposite that used to thread the second threaded portion into engagementwith the entry port.
 21. The universal hemostasis valve adapter of claim16, wherein the first and second threaded protrusions have differentpitches.
 22. A method for securing a medical device with a hemostasisvalve comprising: inserting an adapter tool into an inlet port of ahemostasis valve while an elongate medical device is positioned within alumen of the adapter tool; and engaging at least one protrusion thatextends outwardly from the lumen of the adapter tool with a sealcomponent of the inlet port of the hemostasis valve.
 23. The method ofclaim 22, wherein engaging comprises engaging the adapter tool byrotating the adapter tool to engage at least a portion of the at leastone protrusion that is shaped as a thread that extends at leastpartially about a tapered body portion of the adapter tool.
 24. Themethod of claim 23, wherein the rotating comprises rotating the adaptertool in a clockwise direction when a size of the inlet port of thehemostasis valve is a first size, and rotating the adapter tool in acounterclockwise direction when the size of the inlet port of thehemostasis valve is a second size.
 25. The method of claim 22, whereinthe elongate medical device comprises at least one of a sheath, anextender, or a catheter.
 26. An adapter device for a medical devicecomprising: a body portion having a leading connection surfaceconfigured to engage an inlet port of a hemostasis valve; the bodyportion defining a lumen to receive a medical device for passage of themedical device into the hemostasis valve; the leading connection surfaceof the body portion including one or more protrusions axially spacedapart along a longitudinal axis of the body portion to sealingly engagewith a component of the inlet port of the hemostasis valve.
 27. Theadapter device of claim 26, wherein the one or more protrusions comprisea series of annular ring protrusions having different outer diameters.28. The adapter device of claim 26, wherein the one or more protrusionscomprise at least one threaded protrusion.
 29. The adapter device ofclaim 26, wherein the leading connection surface comprises generallytapered annular surface having said one or more protrusion extendingoutwardly therefrom.
 30. An system for securing a medical device to amedical valve instrument, comprising: a medical device having anelongate body and an exterior surface; an adapter tool defining a lumenalong a longitudinal axis, the elongate body of the medical device beingpositioned with the lumen of the adapter tool so as to provide a sealedengagement between the adapter tool and the exterior surface of themedical device, wherein the adapter tool comprises: a body portionhaving a leading connection surface configured to couple with an inletport of a hemostasis valve, the body portion surrounding the lumen andthe medical device therein, the leading connection surface of the bodyportion being sized and shaped to sealingly engage with a component ofthe inlet port of the hemostasis valve.
 31. The system of claim 30,wherein the adapter tool further comprises one or more protrusionsextending from the leading connection surface and being axially spacedapart along the longitudinal axis of the body portion to sealinglyengage with a component of the inlet port of the hemostasis valve 32.The system of claim 31, wherein the one or more protrusions comprise aseries of annular ring protrusions having different outer diameters. 33.The system of claim 31, wherein the one or more protrusions comprise atleast one threaded protrusion.
 34. The system of claim 30, wherein theleading connection surface comprises generally tapered annular surface.35. The system of claim 30, further comprising the hemostasis valve.